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510(k) Data Aggregation
K Number
K250232Device Name
Vathin® Video Bronchoscope System
Manufacturer
Hunan Vathin Medical Instrument Co., Ltd.
Date Cleared
2025-07-25
(179 days)
Product Code
EOQ
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
Hunan Vathin Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K251599Device Name
Single-use Ureteral Access Sheath
Manufacturer
Hunan Vathin Medical Instrument Co., Ltd.
Date Cleared
2025-07-03
(37 days)
Product Code
FED
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Hunan Vathin Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K240167Device Name
Single-use Ureteral Access Sheath
Manufacturer
Hunan Vathin Medical Instrument Co., Ltd.
Date Cleared
2024-10-08
(260 days)
Product Code
FED
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Hunan Vathin Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.
Device Description
The Single-use Ureteral Access Sheath is a prescription device intended to provide physicians with access to the urinary tract and the capability to serve as a pathway for device exchanges. Similar to all ureteral access sheath sets, this device also safeguards the ureter during device exchanges, thus helping to minimize tissue trauma. The Single-use Ureteral Access Sheath consists of two components: the inner semi-rigid dilator assembly and the outer semi-rigid sheath assembly, both of which have a hydrophilic coating to allow for smooth and easy deployment into the upper tracts over a preplaced ureteral guidewire. The sheath has a locking mechanism that attaches to the luer lock hub of the inner dilator, allowing the sheath and dilator to move as a single unit. To ease the insertion of the Single-use Ureteral Access Sheath into the body orifice, the dilator is advanced over a 0.038 inch guidewire. Since both the sheath and dilator are radiopaque, they can be monitored using X-ray (fluoroscopy) to ensure their accurate positioning during the placement process. The Single-use Ureteral Access Sheath is designed to accommodate endoscopes and other urological instruments with an outer diameter (OD) that is compatible with the sheath's inner diameter (ID) of 10Fr, 11Fr, 13Fr, and 14Fr. The inner layer of the sheath is made of stainless steel to provide radial rigidity that remains patent and intact after the dilator is removed, allowing endoscopes and other urological instruments to pass easily along the lumen of the Access Sheath. The Single-use Ureteral Access Sheath is offered in five French size combinations: 10Fr/12Fr, 11Fr/13Fr, 12Fr/14Fr, 13Fr/15Fr, and 14Fr/16Fr, and two lengths: 35cm and 45cm. The device is constructed using biologically safe materials and is provided in a sterile condition, intended for single use only.
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K Number
K241434Device Name
Video Ureteroscope System
Manufacturer
Hunan Vathin Medical Instrument Co., Ltd.
Date Cleared
2024-10-04
(136 days)
Product Code
FGB
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Hunan Vathin Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K231135Device Name
Video Ureteroscope System
Manufacturer
Hunan Vathin Medical Instrument Co., Ltd.
Date Cleared
2024-01-17
(271 days)
Product Code
FGB
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Hunan Vathin Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Single-use Flexible Ureteroscope is designed for use with Vathin Display Units, endotherapy accessories and other ancillary devices for the endoscopy and endoscopic surgery within urinary tract and kidney in adults.
The Digital Video Monitor is specially designed to be used with medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
Device Description
The Video Ureteroscope System consists of Single-use Flexible Ureteroscope (Model:US-S2600, US-E2600) and Digital Video Monitor(Model:DVM-B1) . During diagnosis and treatment with the Video Ureteroscope System, the Single-use Flexible Ureteroscope is inserted into the ureter or into the kidney or renal pelvis through the ureter, and the image sensor (CMOS) at the end of the Single-use Flexible Ureteroscope converts the received mucosal reflected light signals into electrical signals , transmitted to the Digital Video Monitor through the cable, the Digital Video Monitor receives the image signal from the endoscope and processes it, converts it into an image signal that can be displayed on the display screen, and finally presents it on the screen of the display.
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K Number
K230536Device Name
Single-use Flexible Rhinolaryngoscope; Digital Video Monitor
Manufacturer
Hunan Vathin Medical Instrument Co., Ltd.
Date Cleared
2023-06-14
(107 days)
Product Code
EOB
Regulation Number
874.4760Why did this record match?
Applicant Name (Manufacturer) :
Hunan Vathin Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Single-use Flexible Rhinolaryngoscope is designed to be used with the Digital Video Monitor, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible.
The Digital Video Monitor is specially designed to be used with endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The Vathin® Video Rhinolaryngoscope System is for use in a hospital environment.
Device Description
The Vathin® Video Rhinolaryngoscope System consists of Single-use flexible Rhinolaryngoscope (eight models shown in below) and Digital Video Monitor (model: DVM-A1, DVM-A2, DVM-B1, DVM-B2) for clinical image processing and display.
The Single-use Flexible Rhinolaryngoscope is designed for use with Vathin Display Units, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible.
The Digital Video Monitor is specially designed to be used with compatible Vathin endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
There are eight subject nasopharyngoscope models: RL-S1800, RL-S1801, RL-E1800, RL-E1801, RL-S1E00, RL-S1E01, RL-E1E00, RL-E1E01. The main differences between product models are in the working channel inner diameter (whether channel is present or not), outer diameter, and rotate function.
Single-use flexible Rhinolaryngoscope is a sterile single Rhinolaryngoscope. Digital Video Monitor is a reusable monitor.
The light emitted by the LED cold light source of the Single-use flexible Rhinolaryngoscope lens is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is imaged on the CMOS (complementary metal oxide semiconductor). The CMOS acquisition image is controlled by the CMOS drive circuit, and the standard color video signal is output to the Digital Video Monitor via the encoding circuit. The Digital Video Monitor adjusts the brightness of the light source or corrects the image according to the video signal output from the CMOS, and outputs the corrected standard color video signal.
Single-use flexible Rhinolaryngoscope has the following physical and performance characteristics:
- Maneuverable tip controlled by the user .
- Flexible insertion cord .
- Camera and LED light source at the distal tip .
- . Sterilized by Ethylene Oxide
- For single use
The differences between the Single-use flexible Rhinolaryngoscope models are as follow:
- . Have or haven't working channel
- . Working channel inner diameter
- . Insertion tube outer diameter
- . The length of insertion tube
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K Number
K230200Device Name
Single-Use Flexible Ureteroscope
Manufacturer
Hunan Vathin Medical Instrument Co., Ltd.
Date Cleared
2023-05-18
(113 days)
Product Code
FGB
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Hunan Vathin Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Single-use Flexible Ureteroscope is designed for use with Vathin Display Units, endotherapy accessories and other ancillary devices for the endoscopy and endoscopic surgery within urinary tract and kidney in adults.
Device Description
The Single-use Flexible ureteroscope can be connected to the compatible Vathin Display Units and other accessories for the endoscopy and endoscopic surgery within urinary tract and kidney in adults. The Single-use Flexible ureteroscope is provided sterile (sterilized by EO) and intended to be single-use. The compatible Digital Video Monitor: Model: DVM-A1. The Single-use Flexible ureteroscope and Display Unit make up the video ureteroscope system. During diagnosis and treatment with the video ureteroscope system, the Single-use Flexible ureteroscope is inserted into the ureter or into the kidney or renal pelvis through the ureter, and the image sensor (CMOS) at the end of the Single-use Flexible ureteroscope converts the received mucosal reflected light signals into electrical signals, transmitted to the Display Unit through the cable, the Display Unit receives the image signal from the endoscope and processes it, converts it into an image signal that can be displayed on the display screen, and finally presents it on the screen of the display. There are 4 models of Single-Use Flexible Ureteroscope, the difference between US-S170 and US-E170,US-S180 and US-E180 lies in the US-SXXX series with self-lock and suction function, US-EXXX series does not come with self-lock and suction functions, the rest is exactly the same. The difference between the 2 models of US-EXXX series lies in work channel ID, head OD and outer diameter of main hose OD, while the rest are exactly the same. The difference between the 2 models of US-SXXX series also lies in work channel ID, head OD and outer diameter of main hose OD, and the rest are the same. The Single-use Flexible Ureteroscope includes insertion part, control part, connection part. The control part is made with ABS, contacted with users. The insertion part, as the part connected with patients, includes the sheath which is braided tube made with PEBAX tube, the bending section and the distal end. The bending section is made of snake bone, covered with snake bend eraser. The distal end is made of sensor and LED.
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K Number
K223836Device Name
Vathin® Video Bronchoscope System
Manufacturer
Hunan Vathin Medical Instrument Co., Ltd.
Date Cleared
2023-05-15
(144 days)
Product Code
EOQ
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
Hunan Vathin Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vathin® H-SteriScopeTM I Single use flexible Video Bronchoscope has been designed to be used with the Vathin® Displaying Unit, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Vathin® Video Bronchoscope System is for use in a hospital environment.
Device Description
Not Found
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K Number
K221580Device Name
Single-Use Flexible Cystoscope
Manufacturer
Hunan Vathin Medical Instrument Co., Ltd.
Date Cleared
2022-11-18
(170 days)
Product Code
FAJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Hunan Vathin Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.
Device Description
The Single-use Flexible Cystoscope can be connected to the compatible Vathin Display Units and other accessories for the endoscopy and treatment of adult bladder.
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K Number
K221581Device Name
Single-Use Flexible Rhinolaryngoscope
Manufacturer
Hunan Vathin Medical Instrument Co., Ltd.
Date Cleared
2022-11-18
(170 days)
Product Code
EOB
Regulation Number
874.4760Why did this record match?
Applicant Name (Manufacturer) :
Hunan Vathin Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Single-use Flexible Rhinolaryngoscope is designed for use with Vathin Display Units, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible.
Device Description
The Single-use Flexible Rhinolaryngoscope can be connected to the compatible Vathin Display Units and other accessories for examination and treatment of nasal cavity and upper respiratory tract. There are eight subject nasopharyngoscope models: RL-S1800, RL-S1801, RL-E1800, RL-E1801, RL-S1E00, RL-S1E01, RL-E1E00, RL-E1E01. The main differences between product models are in the working channel inner diameter (whether channel is present or not), outer diameter, and rotate function.
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